(151 days)
The Agile Esophageal Partially Covered OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
The Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
The Agile Esophageal 23mm Partially Covered and Fully Covered Over the Wire (OTW) Stent System is comprised of a metallic implantable stent pre-loaded inside of a flexible delivery system. The stent is made from braided Nitinol wires which form a self-expanding. radiopaque (RO) cylindrical mesh. The stent has flares at each end to aid in minimizing migration after the stent is placed in the esophagus. The flares are a wider diameter than the stent body. The wire ends are looped at the end of the stent. The proximal and distal stent ends each have a continuous suture threaded around their circumferences. The suture is intended to aid in removal or repositioning during the initial stent placement procedure, to be used in the event of incorrect placement. The stent is available in either partially covered or fully covered configurations. The stent is covered with a silicone polymer to restrict turnor in-growth through the wire mesh and to occlude concurrent esophageal fistulas. The proposed stent is nearly identical in design to its predicate Agile Esophageal Stent System (K180144). The main difference between the proposed and the predicate stent is the type of delivery system used with the stent. The proposed Agile Esophageal OTW Stent is intended to be used with an over-the-wire delivery svstem. whereas the predicate Agile Esophageal Stent used a through-the-scope delivery system.
The over-the-wire delivery system is a co-axial tube design. The exterior tube is used to constrain the stent before deployment and to reconstrain the stent after partial deployment. The exterior tube has clear distal section so that the constrained stent is visible. A yellow transition zone on the inner tube of the delivery system is visible between the stent and the blue outer sheath. The system has RO and visual markers to aid in accurate stent placement.
The provided text describes a submission to the FDA for the Agile Esophageal OTW Stent System, establishing substantial equivalence to previously cleared predicate devices. The submission focuses on bench testing and biocompatibility to demonstrate this equivalence, rather than a clinical study evaluating the device's diagnostic performance with human readers and AI.
Therefore, many of the requested criteria related to clinical performance, expert ground truth, and AI assistance cannot be extracted from this document.
Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance attributes for the device, and the acceptance criteria are implicitly that the device "PASS" these tests, demonstrating substantial equivalence to the predicate devices.
| Component | Acceptance Criteria (Product Specification) | Reported Device Performance |
|---|---|---|
| Delivery System | Visual Transition Zone Length | PASS |
| Delivery System | Reconstrainment Band to Distal Inner Bond | PASS |
| Delivery System and Stent | Delivery System Withdrawal / Removal | PASS |
| Delivery System and Stent | Deployment Force | PASS |
| Delivery System and Stent | Reconstrainment Force | PASS |
| Stent | Stent Hoop Expansion Force | PASS |
| Stent | Stent Hoop Compression Force | PASS |
| Stent | Stent Flexibility | PASS |
| Stent | Stent Fatigue Resistance | PASS |
| Stent | Cover Fatigue Resistance | PASS |
Additionally, for biocompatibility:
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | According to ISO 10993-1; All acceptance criteria met for Cytotoxicity, Irritation, Sensitization Testing (stent component subset, delivery system complete set) | All acceptance criteria were met. |
2. Sample size used for the test set and the data provenance
The study conducted was a bench testing for mechanical performance and biocompatibility testing. The document does not specify a "test set" in the context of patient data or image data. Therefore, details like country of origin or retrospective/prospective nature are not applicable. The sample size for each specific bench test is not provided in this summary, only the outcome.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a medical implant (stent) and its submission is based on engineering performance data and biocompatibility, not on diagnostic performance where human experts establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human expert adjudication on a test set (e.g., medical images) was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done, and the device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" or reference for acceptance was the product specifications of both the proposed device and its nearly identical predicate devices. For biocompatibility, the ground truth was compliance with ISO 10993-1.
8. The sample size for the training set
Not applicable, as this is a physical medical device, not a machine learning model. There is no training set in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”